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System Support Engineer I/II

Company: Tranzeal Incorporated.
Location: Santa Clara
Posted on: January 24, 2023

Job Description:

Role: System Support Engineer I/II
Location: Santa Clara, CA
System Support Engineer I/II for Process and Support Department (Global Development)
1. Working under general supervision, the Systems Support Engineer will perform the following activities according to approved procedures:
a. Preventative maintenance (PM's)
b. Installation/operational qualifications (IOQ's)
c. Troubleshooting and repairs
d. Install/deinstall/move instruments and computer work stations
e. Install software
2. All activities performed are documented accurately and in a timely manner in the electronic instrument database according to approved procedures
3. Provide limited IT support to laboratory systems
4. Provide effective and professional customer support at all times
5. Learn to solve a variety of problems of diverse scope and complexity under supervision
6. Learn to analyze alternative approaches to creatively solve problems and/or develop new perspectives on existing solutions under supervision
7. Establish internal/cross-functional/customer relationships
8. Comply with safety policies, practices and procedures at all times. Maintain safe work habits and practices with regard to safety requirements both in-house and externally at external study sites.

Additionally, this position include logistics responsibilities that supports a team of Service Engineers and Application Specialists within the Development department at Roche Molecular Diagnostics for a variety of activities. Including, but not limited to:

--- Coordinate IQ/OQ documentation: request document number from TrackWise, assemble hardcopy IOQ documentation, obtain pre-execution signatures, give IOQ document to service engineer to execute, scan approved reports, update TrackWise ticket for completion, and ship approved IOQ documents to NJ
--- Regularly update the team dashboard on status of instrument maintenance, IOQ, and repair activities
--- Induct new instruments to the instrument management database (RAM) to record status, location, and service events, etc.
--- Request instrument updates in RAM by submitting general requests for IOQs, relocation, etc. and/or updating the instrument information in the database per request(s)
--- Update instrument signage/logsheets in the labs, update instrument logsheets on a quarterly basis, and perform regular lab checks to assess instrument status
--- Facilitate requests for instrument service contract quotes from vendors and creation of Purchase Orders (PO's)
--- Track vendor quotes, service POs and instrument contacts (vendors & users)
--- Call and schedule vendor maintenance and service visits for in-house equipment and escort vendor technicians/engineers to appropriate lab(s)
--- Proxy work orders in RAM for vendor-performed IQ/OQs, PMs and repairs
--- Maintain reagent inventory for instrument maintenance and OQs, as appropriate
--- Support team members by shipping parts and reagents to external sites, as needed
--- Reconcile logsheets quarterly against RAM database

--- Associates degree in electrical or electronic engineering or equivalent training with job related experience
--- 0 - 1 + years in medical device industry (level I) or 2+ years in medical device industry (level II) relevant work experience with basic knowledge of instrument support
--- Demonstrated proficiency to learn new skills/software/tools rapidly
--- Must be able to consistently follow instructions with a cooperative, "can do" attitude
--- Excellent written and verbal communication skills, with a professional demeanor
--- Meticulous attention to detail to accurately document activities in validated software tools
--- Strong organizational, multi-tasking, and time management skills
--- Ability to be flexible with changing work priorities and follow procedures and/or supervisor instructions with a cooperative, can-do attitude and strong work ethic
--- Excellent follow-through on assigned action items to ensure prompt support is provided to RMD staff working both internally and at external sites
--- Must comply with all RMD safety policies and requirements (training provided)
--- Experience in customer service/support and with spreadsheet software program (e.g., Excel, Google Sheet)

--- Bachelor's degree or equivalent in engineering or related field
--- 0 - 1 + years in medical device industry (level I) or 2+ years in medical device industry (level II) , preferably "hands on " experience with medical instrument maintenance
--- Basic understanding of molecular diagnostics products
--- Working knowledge of hand tools and electronic test equipment
--- Knowledge of Quality System Requirements (QSR), In Vitro Diagnostics Directive requirements (IVDD), and customer service concepts
--- Excellent inter-personal and customer relation skills

Position Requirements:
--- This position is based in Santa Clara, CA with some work performed in Pleasanton, CA (1-5 days per month based on business needs)
--- Must maintain a valid driver's license


Keywords: Tranzeal Incorporated., Santa Clara , System Support Engineer I/II, Other , Santa Clara, California

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